The following data is part of a premarket notification filed by Grandway Technology (shenzhen) Limited with the FDA for Digital Automatic Blood Pressure Monitor Bpm11 Series.
| Device ID | K120675 |
| 510k Number | K120675 |
| Device Name: | DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong, CN 518118 |
| Contact | Patrick Chow |
| Correspondent | Patrick Chow GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED ZHU KENG INDUSTRIAL ZONE PING SHAN, LONG GANG DISTRICT Shenshen, Guang Dong, CN 518118 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-05 |
| Decision Date | 2013-02-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04895045403598 | K120675 | 000 |
| 00853455007144 | K120675 | 000 |